Orthopedic device and method for securing the same

ABSTRACT

An orthopedic device has various frame elements concealed by a sleeve defining pockets into which such frame elements are located. The orthopedic device includes a strap tightening assembly adapted to secure a plurality of straps simultaneously. The frame may include flexible edge features located along a periphery thereof

FIELD OF THE DISCLOSURE

The present disclosure relates to an orthopedic device, and moreparticularly to an orthopedic device that provides stability,protection, support, rehabilitation, and/or unloading to a portion ofthe human anatomy in a streamlined and light manner.

BACKGROUND

Known orthopedic devices are used for providing stability, protection,support, rehabilitation and/or unloading a portion of the human anatomy.Known devices, however, are often considered as being physically bulky,heavy, and costly requiring numerous manufacturing processes to beproduced.

An example of an orthopedic device is a knee brace. As is wellunderstood, knee braces are widely used to treat a variety of kneeinfirmities. Such braces may be configured to impart forces or leverageon the limbs surrounding the knee joint to relieve compressive forceswithin a portion of the knee joint, or to reduce the load on thatportion of the knee. If knee ligaments are weak and infirm, a knee bracemay stabilize, protect, support, unload, and/or rehabilitate the knee.

The knee is acknowledged as one of the weakest joints in the body andserves as the articulating joint between the thigh and calf musclegroups. The knee is held together primarily by small but powerfulligaments. Knee instability arising out of cartilage damage, ligamentstrain, and other causes is relatively commonplace since the knee jointis subjected to significant loads during the course of almost any kindof physical activity requiring legs.

A healthy knee has an even distribution of pressure in both its medialand lateral compartments. It is normal for a person with a healthy kneeto place a varus moment on the knee when standing so pressure betweenthe medial and lateral compartments is uneven but still natural.

Compartmental osteoarthritis is a problematic type of knee infirmity. Itmay arise when there is a persistent uneven distribution of pressure inone of the medial and lateral compartments of the knee.

Compartmental osteoarthritis can be caused by injury, obesity,misalignment of the knee, or due to aging of the knee. A major problemresulting from osteoarthritis is that smooth cartilage lining the insideof the knee wears away. This leads to a narrowing of the joint space dueto the development of cysts and erosions in the bone ends. Because ofthe narrowing of the joint, bone comes directly in contact with bone,and an uneven distribution of pressure develops across the knee, whichmay cause the formation of bone spurs around the joint. All of thesechanges ultimately lead to increasing pain and stiffness of the joint.

While there are no cures to osteoarthritis, there are many treatments.Individuals who have a diagnosis of isolated lateral or medialcompartmental osteoarthritis of the knee are confronted with a varietyof treatment options such as medications, surgery, and nonsurgicalinterventions. Nonsurgical interventions include using canes, lateralshoe wedges, and knee braces.

Knee bracing is useful in providing compartment pain relief by reducingthe load on the compartment through applying an opposing external valgusor varus moment about the knee joint. Unloading knee braces have beenshown to significantly reduce osteoarthritis knee pain while improvingknee function.

While known knee braces succeed at reducing pain or at stabilizing aknee joint, many users find these braces to be bulky, difficult to don,complicated to configure, and uncomfortable to wear. The exemplaryembodiments described have streamlined features capable of providingrelief for medial or lateral compartmental osteoarthritis, or functionalstability of the knee without the attendant drawbacks of known unloadingknee braces.

The concepts described with the exemplary knee brace embodiments may beextended to a variety of wearable devices configured to be secured toand/or support numerous portions of anatomy.

SUMMARY

The embodiments of the orthopedic device are described in the context ofa knee brace for providing relief to users with complications of theknee, such as with osteoarthritis. The embodiments offer a knee bracehaving a low profile and simpler to use than conventional braces aimedat treating osteoarthritis of the knee. The knee brace embodimentsdefine a sleeve-like configuration concealing and confining certainbrace components such as straps and portions of the frame. In thismanner, the hidden mechanics provide a discreet appearance with easyaccess, with or without the zipper described below, for initial fitrequirements and adjustment.

The embodiments offer a lighter and versatile knee brace, and mayinclude a soft inner sleeve segment that makes the brace easier to donand off. A single adjustment mechanism allows for a plurality of strapsto be simultaneously adjusted without necessity for adjustment of otherstraps. Zipper configurations assist the user to don and doff the brace,especially those with irregular or disproportionate body types with poorhand dexterity in their hands. The combination of a sleeve and zippersimplifies the donning and doffing process, particularly in view of theuser being able to slide the brace on in its entirety. The zipper allowsaccess to various components of the brace ordinarily concealed duringnormal use of the brace. The components of the brace are trimmable andadjustable to allow use across a spectrum of user profiles andanatomies.

In an embodiment, the orthopedic device includes an inner sleeve segmenthaving interior and exterior surfaces, a frame applied over the outersurface of the inner sleeve, at least one strap connected to the frame,and an outer sleeve segment connected to the inner sleeve segment andhaving interior and exterior surfaces with the interior surface facingthe interior surface of the inner sleeve segment. A portion of the framemay be confined within a space defined between the outer and innersleeve segments forming a definitive sleeve.

The outer sleeve segment may extend over only a portion of the innersleeve to define a pocket into which a portion of the frame extends,such as a frame shell. The pocket may include openings to permitelements of the knee brace to extend outwardly from the shell within thepocket, and such elements may include a strap, strut, hinge or otherbrace component. The outer sleeve segment may include reinforcementedging about the openings and/or the periphery of the outer sleevesegment to improve durability of the periphery of the outer sleevesegment and improve the ornamental appearance of the device.

The inner and outer sleeve segments are preferably formed fromlatex-free fabrics. The interior surface of the inner sleeve segment issoft and comfortable to the touch and provides a barrier from the framefor skin-sensitive users. The inner sleeve segment may include paddingincorporated therewith and associated with the frame to eliminate anecessity for additional padding that may attribute to increased weight.

In a variation, the orthopedic device may include multiple outer sleevesegments for concealing or covering various components over certainlengths over the inner sleeve segment.

The inner sleeve segment may extend the entire length of the orthopedicdevice, only over a portion of the length of the orthopedic device, ormay have multiple segments defining various sections of an innerperiphery of the orthopedic device.

In a variation, the outer sleeve segment may extend the entirety of thelength of the inner sleeve segment, and the combination of the inner andouter sleeve segments may define an entirety of the length of theorthopedic device.

The frame is selectively accessible from the outer surface of the outersleeve in that a user or clinician can withdraw portions of the framefrom the sleeve for adjustments. From this arrangement, the orthopedicdevice is easily modifiable and can be adjusted during the treatment ofa user, including changing the length of the at least one strap andcustomizing the frame to suit the anatomy of a user.

The orthopedic device may include a tensioning mechanism coupling afirst end of the at least one strap to the frame. The tensioningmechanism provides incremental adjustment of the first end of the atleast one strap relative to the frame among a plurality of predeterminedsettings. The tensioning mechanism may be mounted to an outer surface ofthe frame and is preferably accessible from and through the exteriorsurface of the outer sleeve segment.

The tensioning mechanism may include a rotary ratchet and a windingmechanism. The first end of the at least one strap may be coupled to thetensioning mechanism by a cable windable about the winding element; therotary ratchet keeps the winding element from releasing unless thewinding element is selectively released by the user. The tensioningmechanism allows for simple and repeatable dosing of pain-relievingforces, particularly simplifying the adjustment process so two strapscan be finely tensioned simultaneously.

The frame may define upper and lower shells, with a hinge that connectsand spaces them apart. The upper and lower shells may be rigid orsemi-rigid, or alternatively may be flexible but become semi-rigid whenthe at least one strap is tensioned and the orthopedic device is placedsnugly over the leg of the user. When semi-rigid, the shells mayaccommodate movement of the leg of the user, but also firmly secure tothe leg and reinforce the leg. The shells are of a low profile type,thereby reducing the weight of the knee brace.

The frame preferably defines a “single upright frame” in that strutsconnect the upper and lower shells to one another along a single side ofthe brace. The knee brace is considered lightweight in that itpreferably has a weight in the range of 200-500 grams. The struts may bethinner over conventional struts, particularly since they combine withthe sleeve to secure over the leg of the user. The struts are connectedto one another by a hinge.

The at least one strap may be adjustable in length within the spacebetween the outer and inner sleeve segments. The at least one strap mayhave first and second ends connecting to and spiraling between the upperand lower shells. The first and second ends may connect at a first sideof the upper and lower shells, and extend over a second side of thebrace located opposite to the first side at which the hinge is located.

In a variation, the at least one strap has first and second endsconnected to the frame, the first end of the least one strap isadjustably movable relative to the frame and the second end of the atleast one strap is anchored to the frame. The orthopedic device mayfurther comprise a bracket connected to and extending from the at leastone strap. The tightening mechanism may be connected to the frame andcouple the first end of the at least one strap to the frame by thebracket. The tightening mechanism may be arranged to simultaneouslyadjust the at least one strap relative to the frame. The tighteningmechanism includes a winding element, and at least one cable extendsfrom the winding element and couples to the bracket.

The bracket may define a channel through which first and second portionsof the at least one cable extend. The first cable portion secures to theframe at an anchor point, and the second cable portion operativelyengages the tightening mechanism to allow for selective reduction inlength of the second cable portion for adjusting the at least one straprelative to the frame. The channel permits more uniform pulling ormovement of the at least one strap by the cable by distributing thetension of pulling more uniformly across the width of the at least onestrap.

Alternatively or in combination with the channel, the bracket may definean opening through which the cable may also extend and pull the bracketand strap from a single point at the bracket. In this manner, a pullangle of the at least one cable may adjust according to the angle thestrap is at any point in adjustment of the at least one strap.

In an embodiment, the at least one strap defines first and secondstraps. The at least one cable operatively engages first and secondbrackets extending respectively from said first and second straps. Thetightening mechanism is arranged to operatively wind the at least onecable so the first and second straps are adjusted simultaneously.

A guide may be on the frame and extend between the bracket and thewinding element. The guide routes the second cable portion to thewinding element. In a variation, the guide may be pivotally secured tothe frame and pivot according to the angle at which the at least onestrap is arranged relative to the axis or axes of the first and secondstruts. The guide may be also initially adjusted at an angle and securedand maintained at the angle.

The orthopedic device may also have a strap tab bearing tighteningindicia and at the first end of the at least one strap. The strap tab isarranged for substantial adjustment of a length of the at least onestrap, and the tightening mechanism is arranged for finer adjustment ofthe at least one strap relative to the frame.

At least one of the upper and lower shells may define a flexible edgeportion located along a periphery. The upper and lower shells may eachbe formed from a main body, and the flexible edge portion may also beformed from the main body. The flexible edge portion may only be formedalong a side of the upper and lower shells opposite to a side adjacentthe hinge.

A first zipper may be on the outer sleeve and secured to opposed edgesof the outer sleeve to separate the opposed edges and provide access tothe frame and the at least one strap. The first zipper may be at thelower portion of a first side of the orthopedic device, and the at leastone strap may be connected to the frame at the first side of theorthopedic device.

The outer sleeve segment may be defined by at least first and secondmaterial sections. The first material section may generally correspondin shape to the frame, and the second material section may be secured tothe first material section such that the second material section coversportions of the at least one strap extending past the frame. The firstmaterial section may have padding and breathability features differentfrom the second material section.

The numerous advantages, features, and functions of embodiments of theorthopedic device will become readily apparent and better understood inview of the following description and accompanying drawings. Thefollowing description is not intended to limit the scope of orthopedicdevice, but instead merely provides exemplary embodiments for ease ofunderstanding.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevational view according to an outer configurationof an embodiment of the orthopedic device.

FIG. 2 is a front elevational view according to an inner configurationof the embodiment of FIG. 1.

FIG. 3 is a detail view of detail III in FIG. 2 showing a flexible edgeportion.

FIG. 4 is a schematic view showing a medial side of the orthopedicdevice of FIG. 1 in an open thigh mode.

FIG. 5 is a schematic view showing a lateral side of the orthopedicdevice of FIG. 1 in a closed calf mode.

FIG. 6 is a schematic view showing the lateral side of FIG. 5 in an opencalf mode.

FIG. 7 is a detailed view of the outer surface of the upper shell andtensioning device of FIG. 2.

FIG. 8 is a detailed view of the inner surface of the upper shell andtensioning device of FIG. 2.

FIG. 9 is a front elevational view of another embodiment of theorthopedic device having a sleeve.

FIG. 10 is a front elevational view of the embodiment of FIG. 9 withoutthe sleeve.

FIG. 11 is a schematic view of a pocket on the sleeve of the orthopedicdevice of FIG. 9.

FIG. 12 is a detailed view of the inner surface of an upper shell in theorthopedic device of FIG. 9.

FIG. 13 is a detailed view showing a strap tab including tighteningindicia.

FIG. 14 is a detailed view showing attachment of a strap onto a lowershell in the orthopedic device of FIG. 9.

The drawing figures are not necessarily drawn to scale, but instead aredrawn to provide a better understanding of the components, and are notintended to be limiting in scope, but rather to provide exemplaryillustrations. The figures illustrate exemplary configurations of anorthopedic device, and in no way limit the structures or configurationsof an orthopedic device and components according to the presentdisclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Environment and Context

An embodiment of an orthopedic device in the form of a knee brace isprovided to reduce the effect of osteoarthritis in a knee joint and/orstabilize a knee joint weakened by injury or other infirmities. Althoughthe illustrated embodiments show a hinge positioned on the medial sideof the knee brace and the straps positioned on the lateral side of theknee brace, it will be understood that the knee brace may be configuredto reduce or cure both medial and lateral knee joint infirmities. Thehinge may be positioned on the lateral side of the knee brace and thestraps may be positioned on the medial side of the knee brace.

The knee brace embodiments of the disclosure are adapted for a humanknee joint, and may be dimensioned to accommodate different types,shapes, and sizes of human joints, appendages, and other anatomicalportions. Embodiments may be provided to orient principal forces exertedby strap systems of the embodiments at any desirable location to treatknee infirmities.

For explanatory purposes, the knee brace embodiments are described anddivided into sections denoted by general anatomical terms for the humanbody. Each of these terms is used in reference to a human leg divided insimilar sections with a proximal-distal plane extending along themeniscus of the knee between the femur and tibia (i.e., femoral andtibial leg portions, respectively).

The embodiments of the knee brace are also divided into anterior andposterior sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg. Each of the anterior and posterior sections isfurther divided about the center of the knee by a transverse orproximal-distal plane and median, sagittal, or lateral- medial planes.

The anatomical terms described are not intended to detract from thenormal understanding of such terms as readily understood by one ofordinary skill in the art of orthotics. It will also be understood that,while the invention is discussed with a knee brace, the principlesdescribed can be extended to a variety of orthopedic and prostheticdevices, and any other device that would be wearable and employ thefeatures described.

B. Embodiments of the Orthopedic Device

FIG. 1 shows an outer configuration of an orthopedic device 10 in theform of a knee brace for securing about a knee K. The device 10 has anouter sleeve 12 covering various brace components, as disclosed in FIG.2, and including a plurality of straps 28, 30 extending about lateral Land medial M sides of the device and underneath the outer sleeve 12. Atensioning mechanism 18 protrudes from a first side, such as lateralside L, of the device 10.

FIG. 2 shows an inner configuration of the knee brace 10. The brace 10includes an inner sleeve segment 22 having inner and outer surfaces, aframe comprising upper and lower shells 24, 26, respectively connectedto and spaced apart by upper and lower struts 38, 40, respectively,secured to a hinge 16, and the first and second straps 28, 30 connectingto the upper and lower shells 24, 26. The frame, straps, and hinge withthe struts are preferably confined within a space defined between theinner and outer sleeves 12, 22, and concealed along both interior andexterior peripheral surfaces of the device 10.

The shells 24, 26 include padding 44 extending along the inner surfaceof the shells and located adjacent to an inner surface of the innersleeve segment 22. The padding 44 is sandwiched between the shells 24,26 and the inner sleeve segment 22. The padding 44 preferably extendsbeyond the peripheral edges of the shells and along the entirety of theinner surface of the shells.

As shown in detail III depicted in FIG. 3, at least one of the upper andlower shells 24, 26 defines a flexible edge portion located along aperiphery. The lower shell 24 defines the flexible edge portion 42 at alowermost edge opposite the upper most edge adjacent to the hinge 18.The flexible edge portion 42, in this variation, is formed by aplurality of gaps 46 extending a distance into the lower shell from theperiphery of the lower shell 26. A plurality of individually flexiblesections 47 is formed between each of the gaps 46 to form the flexibleedge portion 42.

According to this variation, the lower shell is formed from a main body,and the flexible sections 47 are formed from the main body itself (asopposed to being a structural element apart or separate from the mainbody). Alternatively, the flexible edge portion may be formed from anovermold having softer properties than the main body, as taught in U.S.Pat. No. 7,198,610, granted Apr. 3, 2007, and incorporated herein byreference.

The flexible edge portion 42 may be only formed along a side of theupper and lower shells opposite to a side adjacent the hinge 18, or maybe arranged at any other location along the shells 24, 26. The flexibleedge portion 42, at least in the embodiment of FIG. 3, extends short ofthe padding 44, and beyond the peripheral edge of the shell 26.

Each of the shells may be formed from a flexible, thin, and soft plasticenabling trimming of the dimensions of each of the shells.

Referring to FIG. 2, each of the first and second straps 28, 30 hasfirst and second ends connecting to and spiraling between the upper andlower shells 24, 26. The first and second ends of the straps connect atthe first side, such as the lateral side L, of the upper and lowershells. The straps 28, 30 also extend over to the second side, such asthe medial side M, of the brace located opposite to the first side atwhich the hinge 18 is located. The orientation of the brace can bereversed so that the straps are arranged in an opposite orientation.

The straps are arranged in an orientation so as to treat osteoarthritis,as principally taught in U.S. Pat. No. 7,198,610. The brace is notlimited to two straps and may only include a single strap connecting theupper and lower shells, as likewise taught in U.S. Pat. No. 7,198,610.

Each of the straps 28, 30 is adjustable in length and tensionable withinthe space between the outer and inner sleeve segments 12, 22.

According to the embodiment of FIG. 2, the straps 28, 30 may eachinclude an elastic segment 34 at a first end and connecting to the uppershell 24, and a non-elastic segment 32 extending from the elasticsegment 34. The non-elastic segment 32 preferably forms a majority ofthe length of the straps. Each of the straps may include an anchorsegment 36 at a second end of the straps and is pivotally attached tothe lower shell 26. The anchor segment 36 is preferably more rigid thanthe non-elastic segment 32. The elastic segment allows for gentleadjustment of the strap over the user's leg, whereas the non-elasticsegment is provided to resist movement of the knee to sufficientlyunload a compartment of the knee.

The anchor segment 36 may form a segment of the length of the straps, ormay alternatively be formed as a reinforcement part which extends overat least a portion of the second end of the non-elastic segment 34.Preferably, the anchor segment 36 pivotally connects at an anchoringpivot point 48 to the lower shell to provide adjustability of the secondof the strap relative to the lower shell. The anchor segment may be morerigid than the non-elastic segment, and may be formed by a flexibleplastic piece whereas the non-elastic segment may be formed from atextile. Examples of the non-elastic segment may be found in U.S. Pat.No. 7,198,610 by way of the force and stability straps discussed in thepatent.

The second end of the straps is preferably trimmable in length.According to an embodiment, the anchor segment 36 is removably attachedto the non-elastic segment 32 via a hook and look attachment. The secondend of the non-elastic segment 32 can be removed from the anchor segment36, trimmed in length, and then reattached to the anchor segment 36.

As shown in FIG. 4, the brace 10 includes an upper zipper 20 secured tothe outer and inner sleeve segments 12, 22 and is arranged to separateopposed edges of the outer and inner sleeve segments at a second ormedial side M of an upper portion of the knee brace. The brace 10 istherefore operable at its upper portion corresponding to the user'sthigh, and assists the user when the brace is donned and doffed. Theuser can unzip the upper portion of the brace when donning the brace toaccommodate the thigh and facilitate correct placement of the brace overthe user's knee. Because the outer and inner sleeve segments 12, 22 havesome flexibility, the brace can be tightly secured over the thigh Tafter the upper zipper 20 is zipped.

FIG. 5 shows a lower zipper 50 in a closed configuration and provided onthe outer sleeve 12 to secure opposed edges of the outer sleeve orseparate the opposed edges to provide access to the frame and thestraps, as shown in FIG. 6. The lower zipper 50 is on the first orlateral side L of the brace to allow for better access of the bracecomponents for resizing and adjustment. In this embodiment, the lowerzipper 50 is preferably only on the outer sleeve and may only travelwithin a section of the lower portion of the outer sleeve and may bespaced away from the lower peripheral edge of the outer sleeve, asdepicted in FIG. 6.

In a variation, the lower zipper 50 may extend along any segment orlength of the outer sleeve segment. It may extend between the uppermostand lowermost peripheral edges of the outer sleeve. Other variants areenvisioned in that the lower zipper may not be confined within thelength (corresponding to longitudinal length of the leg), and may splitopen the outer sleeve much in a manner shown and described with theupper zipper.

Multiple zipper configurations may be arranged in that a first zippersegment extends from the uppermost periphery of the outer sleeve to ahinge region generally corresponding to the hinge, and another zipperextends from the lowermost periphery of the outer sleeve to the hingeregion. The zipper or zippers on the outer sleeve may be provided alongany side of the brace and is/are not limited to only the lateral side.

The outer sleeve 12 may define first and second material sections 13,14. The first material section 13 generally corresponds in shape to aframe of the brace, and the second material section 14 is secured to thefirst material section. The second material section 14 covers portionsof the straps 30, 32 extending past the frame.

The first material section has padding and breathability featuresdifferent from the second material section. The first material sectionmay be formed from a spacer material comprising a three-dimensional knitstructure covered by a mesh that provides sufficient breathability,insulation, compression, durability, and recovery. An exemplary materialis produced by Gehring Textiles under product numbers SHR 701, SHR 714or SHR 754F.

The second material section and the inner sleeve segment may beconstructed of the same or different fabrics. Exemplary fabrics includespandex, Lycra, nylon, polyester, OUTLAST, COOLMAX, AEROSPACER,microfiber, three-dimensional fabrics, and other suitable fabrics. Thesleeve is preferably constructed from a latex-free fabric that providesa fabric-lined inner surface preferably providing a soft and comfortablefee and a barrier from the brace for skin-sensitive users.

The sleeve may have various treatments incorporated therein includingantibacterial, scenting, and moisture wicking agents. Frictionalfeatures may be at various locations along the inner surface of theinner sleeve segment. Silicone bands, dots, segments or otherconfigurations may be at the uppermost section of the upper portion ofthe inner sleeve segment to prevent slippage of the brace on the thighof the user. Alternatively, frictional features may be provided alongthe inner surface of the inner sleeve segment corresponding to theshells.

The inner and outer sleeves may have elasticity to allow for the braceto be tightly and comfortably secured over the leg, particularly byapplication of the upper zipper. The elasticity of the inner and outersleeves may remove necessity for circumferential straps provided besidesthe aforementioned straps 28, 30.

Referring to FIGS. 7 and 8, the tensioning mechanism 18 couples a firstend of the straps 28, 30 to the frame. The tensioning mechanism 18provides incremental adjustment of the first end of the straps relativeto the frame among a plurality of predetermined settings. The tensioningmechanism may be a dial tensioning device, a ladder strap or othersuitable incremental tensioning mechanism, as taught in U.S. Pat. No.7,198,610.

The tensioning mechanism may include a rotary ratchet and windingmechanism. The first ends of the straps are each coupled to thetensioning mechanism 18 via a cable 52 having a first end windable aboutthe tensioning mechanism 18 and a second end 60 anchored to the uppershell. The cable 52 has segments 52A, 52B extending from the tensioningmechanism 18 routed through cable guides 54 to a bracket 58 mounted onthe elastic segments 34A, 34B and placed through openings 56 formed bythe upper shell 24 to anchor to the shell. A knob 119 is operativelyconnected to the rotary ratchet and the winding mechanism may protrudeoutwardly from the knee brace and outside the sleeve.

From the arrangement in FIGS. 7 and 8, the first and second straps areeach coupled to and simultaneously adjustable by the tensioningmechanism, permitting the straps to be adjusted with a single mechanism.The elastic segment allows for some ease in the strap to compensate forthe inelasticity of the non-elastic segment preferably provided to applya greater amount of pressure against the knee as the tensioningmechanism is used to apply tension in the straps over the user's leg.The combination of the elastic and non-elastic segments in combinationwith the tensioning mechanism provides a balance in maintainingsufficient tension in the strap to make the straps more comfortable tothe user.

Referring to the orthopedic device 100 of FIGS. 9 and 10, the device 100includes upper and lower shells 102, 104, respectively connected to oneanother by a strut assembly including upper and lower struts 106, 108connected to one another by a hinge 110. The longitudinal axis or axes(when the hinge is bent) of the brace may be considered to generallyextend parallel to the upper and lower struts. First and second straps112, 114 spiral between the upper and lower shells 102, 104. Either ofthe straps 112, 114 may be incrementally adjusted by a tensioning device118 connected to a cable 120 routed about one of the upper and lowershells.

Brackets or tab elements 150, 152 carried by first end portions of thestraps 112, 114 are coupled to the cable 120 and permit adjustmentrelative to the upper and lower shells 102, 104. Second end portions ofthe straps 112, 114 may include fastener tabs 144, 148 coupling toopenings 142, 146, such as those having a keyhole configuration with oneend having a smaller diameter than another end of the opening. At leastone end of the strap includes a strap tab 132 including tighteningindicia.

A lower stability strap 116 may circumferentially extend about a lowerportion of the device in combination with the lower shell 104. Thestability strap 116 may have a first end carrying a fastener tab 138engageable with an opening 140, and a second end looped about an openingdefined by the lower shell 104.

The shells are of a low profile type and are preferably constructed fromplastic, thereby reducing the weight of the knee brace. While the shellsare preferably constructed from plastic, whether it is rigid, semi-rigidor flexible, the shells may be constructed from other known structuralmaterials that are rigid, semi-rigid or flexible. The shells preferablyhave a thickness within the range of 1.0 mm to 5.0 mm and moreparticularly, within the range of 1.5 mm to 2.5 mm. The struts may bethinner over conventional struts particularly since they combine withthe sleeve to secure over the leg of the user, and may be constructedfrom a plastic or metal. An aim of the device is to provide alightweight orthopedic device, and the overall weight of the device ispreferably within the range of 200 to 500 grams.

In this embodiment, the lower shell 104 defines a plurality of flexibleedge tabs 176 spaced apart by gaps 178, and extend from the main bodyportion 174 and along the periphery of the lower shell 104. The flexibleedge tabs are preferably oriented to generally descend downwardly towardthe periphery of the lower shell, but can be oriented in a variety ofdirections to provide optimal pressure relief along the periphery of anyshells used in the brace. The gaps may be uniformly spaced oralternative may be varied in width according to a desired degree ofpressure relief sought in the brace.

It is preferable that the shell is thin so the flexible edge tabs 176can flex over the leg of the user when the brace is worn and theflexible edge tabs can extend continuously from the main body portionwithout interruption. The flexible edge tabs may be formed when thelower shell is created by injection molding or other molding techniquesusing a polymer and forming the flexible edge tabs with the otherportions of the lower shell in the same process step, preceding orsubsequent process step. In this manner, the flexible edge tabs 176provide greater comfort to the user over braces without flexible edges.The flexible edge tabs may have a thickness substantially the same asthe remainder of the main body portion, or may taper in thickness asthey extend to the periphery of the lower shell.

In a variation, the flexible edge tabs may be initially formed in aconnected manner in that material extends between each of the tabs,without the gaps. For example, the tabs may be formed with thinnedsections therebetween which enable a clinician to easily cut the thinnedsections or selectively cut certain thinned sections to separate thetabs from one another and thereby form gaps.

As shown in FIG. 9, the device may include a sleeve 101 having upper andlower pockets 122, 124, respectively, adapted to hold the upper andlower shells 102, 104. The pockets 122, 124 are secured to a sleeve body126. The pockets 122, 124 may be constructed by a thicker or more paddedmaterial than the sleeve body 126 which may be substantially flexibleand breathable, and have characteristics of other sleeve embodimentsdiscussed.

The pockets 122, 124 may include reinforcement edging 128, 130 about thepockets and may also include a surface of hook material for engagingopposing material of the pockets. In a preferred embodiment, thereinforcement edging may be less flexible and have greater toughnessthan material forming the outer sleeve segment. The pockets may includevarious openings 131, 134, 136 for permitting the straps and stabilitystrap to extend about the exterior of the sleeve 101 and be secured tothe shells.

FIG. 11 exemplifies the pocket 122 having an outer flap 123 arranged foropening and exposing at least part of the shell. The pocket 122 includesan inner rim 158 bearing fastener elements over a surface and engageablewith a hook-receivable surface along the outer flap 123. Alternativefasteners may be used such as zippers, buttons, hooks, etc. The innerrim 158 is preferably flexible to permit entry of the shell into thepocket 122 and extends at least a portion of the shell to retain theshell in the pocket. The pocket includes a cavity into which a portionof the shell extends beyond the outer flap.

The outer flap 123 may include an opening or slit 156 through which thestrap 122 may extend when coupled to the shell. The strap 112 may becoupled to the shell via a coupling element, such as a clamping tab 154with hook elements engageable with a hook-receivable surface on thestraps, to a bracket or tab coupled to the cable.

Referring to FIG. 12, the tightening system may include the tensioningdevice 118 adjusted the cable 120 by rotary motion. In this embodiment,as with the embodiment of FIG. 7, both of the straps 112, 114 arepreferably singularly adjusted by the tensioning device 118. The ends ofthe cable 120 at a first portion 121 are anchored at points 164, 166corresponding respectively to the straps 112, 114.

Each of the straps includes the brackets 150, 152 through which thecable 120 extends from the anchor points 164, 166, and the cable has asecond portion 123 which thereafter the cable is routed by guides 160,162 toward the tensioning device in an appropriate manner, such as themanner depicted in FIG. 12. The guides 160, 162 may either be secured inorientation against the frame, or pivotally secured by pivot pin 161.

The brackets 150, 152 may each include a channel 165 through which thecable 120 extends transversely relative to the strap length todistribute tension across the width of the strap when the strap istensioned. The clamping tabs 132, 156 secure to the straps and extendfrom the brackets to permit sizing of the length of the straps. Thebrackets 150, 152 may also define a central opening 167 at an endportion located opposite the end secured to the straps. The centralopening 167 provides means through which the cable may pass and slideaccording to the orientation of the strap relative to an axis of thebrace.

The shells may be configured to receive an end portion of the struts,such that strut 106 is received in a cavity 170 formed by the shell. Inthis manner, the strut and inner surface of the shell define acontinuous surface without protruding relative to one another along theinterior of the shell and are intended to be adjacent to the leg of theuser. In a variation, an indent may be provided in the shell only equalto half of the strut thickness, and the strut is not flush with theshells.

FIG. 13 shows the strap tab 132 in a clamping tab bearing indicia 168the user may employ to understand relative settings of the strap 112.The clamping tab 132 includes hook material on both flaps 172 clampedonto an end of the strap 112. The border of the sleeve at the slit mayserve as an indicator at which the indicia falls when the strap 112 isadjusted.

FIG. 14 exemplifies how the strap 114 may couple to the lower shell 104when the lower shell 104 is placed into the pocket 124. The strap 114carrying the fastener tabs 144 secured to the opening 142. The strap 114extends through the slit or opening 134 defined by the pocket 124 and ispreferably formed about the reinforcement edging 130 located about theperiphery of the pocket 124.

Various methods for donning and doffing the brace may be permitted incombination with the various features and components discussed in viewof the embodiments of the knee brace. A method for donning the brace mayinclude unzipping the upper zipper prior to placing the brace over theuser's leg to open at least the thigh section, and then subsequentlyzipping the upper zipper once the knee brace is properly on the user'sleg to close the brace. The lower zipper may be unzipped to provideaccess to the shells and straps to allow for trimming of the shells andstraps. The straps may be adjusted simultaneously to tension the strapsover the user's leg.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the disclosure. Thus, for example, those skilled in the art willrecognize that the orthopedic device may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features. In addition to the variations described herein,other known equivalents for each feature can be mixed and matched by oneof ordinary skill in this art to construct an orthopedic device inaccordance with principles of the present disclosure. Additionally, itwill be understood by the skilled artisan that the features describedherein may be adapted to other types of orthopedic devices. Hence thisdisclosure and the embodiments and variations thereof are not limited toknee braces, but can be utilized in any orthopedic devices.

Although this disclosure describes certain exemplary embodiments andexamples of an orthopedic device, it therefore will be understood bythose skilled in the art that the present disclosure extends beyond thespecifically disclosed knee brace embodiments to other alternativeembodiments and/or uses of the disclosure and obvious modifications andequivalents thereof. Thus, it is intended that the scope of the presentdisclosure should not be limited by the particular disclosed embodimentsdescribed above, and may be extended to orthopedic devices and supports,and other applications that may employ the features described herein.

1. An orthopedic device, comprising: an inner sleeve segment havinginterior and exterior surfaces; a frame applied over the outer surfaceof the inner sleeve segment; at least one strap connected to the frame;an outer sleeve segment connected to the inner sleeve segment and havinginterior and exterior surfaces with the interior surface facing theexterior surface of the inner sleeve segment, the outer and inner sleevesegments forming a sleeve in which at least a portion of the frame isconfined within a space defined between the outer and inner sleevesegments, and selectively accessible from the outer surface of the outersleeve segment.
 2. The orthopedic device of claim 1, further comprisinga tensioning mechanism coupling a first end of the at least one strap tothe frame, the tensioning mechanism providing incremental adjustment ofthe first end of the at least one strap relative to the frame among aplurality of predetermined settings.
 3. The orthopedic device of claim2, wherein the tensioning mechanism is mounted to an outer surface ofthe frame, the tensioning mechanism accessible from and through theexterior surface of the outer sleeve segment.
 4. The orthopedic deviceof claim 2, wherein the tensioning mechanism is a rotary ratchet andwinding mechanism, the first end of the at least one strap coupled tothe tensioning mechanism via a cable windable about the winding element.5. The orthopedic device of claim 1, wherein the at least one strap isadjustable in length within the space between the outer and inner sleevesegments.
 6. The orthopedic device of claim 1, wherein the frame definesupper and lower shells, and a hinge connecting and spacing apart theupper and lower shells.
 7. The orthopedic device of claim 6, wherein theat least one strap has first and second ends connecting to and spiralingbetween the upper and lower shells, the first and second ends connectingat a first side of the upper and lower shells, and extending over asecond side of the device located opposite to the first side at whichthe hinge is located.
 8. The orthopedic device of claim 1, furthercomprising a first zipper located on the outer sleeve segment andsecured to opposed edges of the outer sleeve segment so as to separatethe opposed edges and provide access to the frame and the at least onestrap.
 9. The orthopedic device of claim 8, wherein the first zipper islocated at the lower portion of a first side of the orthopedic device,the at least one strap connected to the frame at the first side of theorthopedic device.
 10. The orthopedic device of claim 1, furthercomprising reinforcement edging located about a periphery of the outersleeve segment, the reinforcement edging being less flexible and havinggreater toughness than material forming the outer sleeve segment. 11.The orthopedic device of claim 1, wherein the at least one strap hasfirst and second ends connected to the frame, the first end of the leastone strap adjustably movable relative to the frame and the second end ofthe second strap anchored to the frame; the orthopedic device furthercomprising: a bracket connected to and extending from the at least onestrap; a tightening mechanism connected to the frame and coupling thefirst end of the at least one strap to the frame via the bracket, thetightening mechanism arranged to simultaneously adjust the at least onestrap relative to the frame, the tightening mechanism including awinding element, and at least one cable extending from the windingelement and coupling to the bracket.
 12. The orthopedic device of claim11, wherein the bracket defines a channel through which first and secondportions of the at least one cable extend, the first cable portionsecuring to the frame, and the second cable portion operatively engagingthe tightening mechanism.
 13. An orthopedic device, comprising: a framehaving first and second portions opposed from one another; at least oneelongate strap having first and second ends connected to the frame, thefirst end of the at least one strap adjustably movable relative to thefirst frame portion and the second end of the second strap anchored tothe second frame portion; a bracket connected to and extending from theat least one strap; a tightening mechanism connected to the frame andcoupling the first end of the at least one strap to the frame via thebracket, the tightening mechanism arranged to simultaneously adjust theat least one strap relative to the frame, the tightening mechanismincluding a winding element, and at least one cable extending from thewinding element and coupling to the bracket.
 14. The orthopedic deviceof claim 13, wherein the bracket defines a channel through which firstand second portions of the at least one cable extend, the first cableportion securing to the frame, and the second cable portion operativelyengaging the tightening mechanism.
 15. The orthopedic device of claim13, wherein the at least one strap defines first and second straps, theat least one cable operatively engaging first and second bracketsextending respectively from said first and second straps, the tighteningmechanism operatively winding the at least one cable so the first andsecond straps are adjusted simultaneously.
 16. The orthopedic device ofclaim 13, further comprising a guide extending between the bracket andthe winding element, the guide routing the second cable portion to thewinding element.
 17. The orthopedic device of claim 13, furthercomprising a strap tab bearing tightening indicia and located at thefirst end of the at least one strap, the strap tab arranged forsubstantial adjustment of a length of the at least one strap, and thetightening mechanism is arranged for finer adjustment of the at leastone strap relative to the frame.
 18. An orthopedic device, comprising:an inner sleeve segment having interior and exterior surfaces; a frameapplied over the outer surface of the inner sleeve segment; at least onestrap connected to the frame; wherein the frame defines a flexible edgeportion located along a periphery thereof formed from a main body of theframe itself.
 19. The orthopedic device of claim 18, wherein the frameincludes upper and lower shells each formed from a main body, theflexible edge portion being formed by tabs extending from the main bodyspaced apart by gaps.
 20. The orthopedic device of claim 19, wherein theflexible edge portion is only formed along a side of the upper and lowershells opposite to a side adjacent a hinge spacing apart and connectingthe upper and lower shells.